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Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

ConditionsNeurodevelopmental DisordersNeurodevelopmental Disorders (NDD)Neurodevelopmental Disorders and Developmental AbnormalitiesDevelopmental Delay (Disorder)Cerebral Palsy (CP)Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance ImpairmentCerebral Palsy InfantileCerebral Palsy Spastic HemiplegicCerebral Palsy, DyskineticAutism Spectrum DisorderAutism Spectrum Disorder (ASDHypoxic Ischemic EncephalopathyHypoxic Ischemic Encephalopathy (HIE)Traumatic Brain Injury (TBI)Sensory Processing DisorderChromosomal AbnormalitiesGenetic DisordersDown Syndrome (Trisomy 21)Fragile X Syndrome (FXS)RETT Syndrome With Proven MECP2 MutationWilliams Syndrome22q11.2 Deletion SyndromeSensorimotor Integration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-12
SponsorHealing Hope International

About this trial

This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities.

Participants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches.

The purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available.

This study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric participants between approximately 4 and 12 years of age at the time of enrollment.

cerebral palsy

autism spectrum disorder

developmental delay

Disqualifiers

Medical instability or acute medical condition that would prevent safe participation in an intensive therapy program.

Severe uncontrolled seizure activity or other neurologic condition that would interfere with participation in structured therapeutic activities, as determined by the treating clinician.

Behavioral or psychological conditions that would prevent safe engagement in the therapy environment despite appropriate support.

Inability to attend or complete the full two-week intensive program.

Trial population

The study population consists of pediatric participants enrolled in a two week intensive therapy program conducted in a clinical pediatric neurodevelopmental rehabilitation setting. Participants are drawn from a real world clinical population referred for intensive therapy due to functional impairments in motor, sensory, cognitive, communication, and/or regulatory domains. Participants represent a heterogeneous group of children with neurodevelopmental, neurologic, and genetic conditions, including those with acquired brain injury, developmental disorders, and chromosomal abnormalities. Children are referred through clinical providers or caregiver self referral and participate as part of routine care rather than assignment to a research intervention. This population reflects a community based sample of children receiving individualized, high frequency, multimodal therapy in an outpatient intensive program.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Pediatric Intensive Multimodal Neurorehabilitation Cohort

Trial outcomes

Primary outcomes

1

Change in Clinician Assessed Functional Neurodevelopmental Performance

Within participant change from baseline to completion of the 2 week intensive program in individualized clinician assessed neurodevelopmental performance domains used in routine care. Measures may include neural timing accuracy in milliseconds relative to metronome paced motor tasks, oculomotor performance scored by saccadic eye movements and horizontal pursuits, primitive reflex integration scored on a 0-5 scale, processing speed/visual scanning completion time, bilateral coordination, crossing midline, sustained attention duration, tactile or stimulation tolerance, executive functioning, emotional regulation, communication intent, and participation in non preferred activities. Each participant is assessed only on domains relevant to their presentation, consistent with the source document's individualized assessment model.

Time frame
Baseline to end of 2 week intensive program

Secondary outcomes

1

Change in Neural Timing Accuracy

Change in neural timing performance during metronome paced motor sequencing tasks, recorded as milliseconds from target rhythm and/or number of steps completed at target accuracy.

Time frame
Baseline to end of 2 week intensive program
2

Change in Oculomotor Control

Change in oculomotor performance assessed by clinician-scored saccadic eye movements and horizontal pursuits, recorded as number correct out of 16 when applicable.

Time frame
Baseline to end of 2 week intensive program
3

Change in Primitive Reflex Persistence

Change in primitive reflex persistence or integration assessed by clinician rating on a 0 to 5 scale and/or reflex status. Reflexes assessed may include TLR, ATNR, STNR, MORO, Rooting, Palmar, Spinal Galant, Spinal Perez, and Babkin, depending on participant presentation.

Time frame
Baseline to end of 2 week intensive program
4

Change in Processing Speed and Visual Scanning Time

Change in processing speed and visual scanning measured by time to complete structured scanning tasks. Depending on participant presentation, tasks may include color, number, word, color-word, 69 arrows, and BD69 scanning activities, as well as sorting number/shape/color. Lower completion time indicates improvement.

Time frame
Baseline to end of 2-week intensive program

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Healing Hope International

Lead sponsor

Source ClinicalTrials.gov
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